High-definition transcranial direc… for Parkinson's (NCT03025334)
Improve thinking via scalp stimulation
- Trial ID
- NCT03025334
- Official Title
- Transcranial Direct Current Stimulation Treatment of Cognitive Dysfunction in Parkinson's Disease
- Goal
- Improve thinking via scalp stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Manitoba
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Interventions
- High-definition transcranial direct current stimulation
Summary For Families
The trial aims to treat the slow-developing thinking and memory problems that many people with Parkinson's get, focusing on mild cognitive impairment before full dementia. It tests high-definition transcranial direct current stimulation, a gentle, non-invasive electrical stimulation of the scalp over the front part of the brain on the left and/or right side, paired with a personalized brain-network analysis to try to restore connections to a deep brain area called the right caudate that was linked to thinking scores. Participants must be over 40, have a confirmed diagnosis of Parkinson's disease, be non-demented based on the Montreal Cognitive Assessment (MoCA), able to give written consent, and fluent in English. People are excluded if they have dementia (MoCA below 18), abnormal magnetic resonance imaging (MRI), metal implants or a pacemaker, recent stroke or seizure history, severe involuntary movements that would spoil scans, pregnancy, or major heart problems.
Locations
- University of Manitoba, Winnipeg, Manitoba, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying High-definition transcranial direct current stimulation. The trial aims to treat the slow-developing thinking and memory problems that many people with Parkinson's get, focusing on mild cognitive impairment before full dementia. It tests high-definition transcranial direct current stimulation, a gentle, non-invasive electrical stimulation of the scalp over the front part of the brain on the left and/or right side, paired with a personalized brain-network analysis to try to restore connections to a deep brain area called the right caudate that was linked to thinking scores. Participants must be over 40, have a confirmed diagnosis of Parkinson's disease, be non-demented based on the Montreal Cognitive Assessment (MoCA), able to give written consent, and fluent in English. People are excluded if they have dementia (MoCA below 18), abnormal magnetic resonance imaging (MRI), metal implants or a pacemaker, recent stroke or seizure history, severe involuntary movements that would spoil scans, pregnancy, or major heart problems.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 10 years and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.